Major abdominal surgery for a number of diseases involving different parts of the gastro-intestinal and urinary tract can result in a patient being left with an abdominal stoma. The three most common types of abdominal stoma are the colostomy, the ileostomy, and the ileal conduit. In the case of an ileostomy, ileal conduit, and many colostomy operations, the patient is unable to control the passage of bodily waste material and must rely upon an appliance attached to their body to collect this material.
Several systems have been employed in the past for this purpose. Colostomates normally employ a disposable appliance which is either a one-piece or two-piece unit. The term disposable refers to the fact that the pouch or bag portion of the unit can be disposed of after a single use. A closed end pouch sealed along all of its edges with only an opening for the stoma is suitable for this purpose. The two-piece disposable unit consists of such a bag suspended from a reusable mounting ring that is supported by a belt. The one-piece disposable unit can be a disposable bag having an adhesive face plate which is attached directly to body as shown in U.S. Pat. No. 3,055,368, a disposable bag having a mounting gasket which is supported by a belt and can include a sealing ring of karaya and glycerol as shown in U.S. Pat. No. 3,302,647, or a disposable bag supported by a sealing ring of karaya and glycerol, an adhesive ring, and a belt as shown in U.S. Pat. No. 3,351,061.
Persons having an ileostomy or urinary stoma normally employ a permanent (i.e., reusable) system or a semi-permanent system. This refers to the fact that the waste collecting bag or pouch has a valve or other type of closure means at the bottom. This permits the unit to remain on the body for several days. Again, these systems are available as either a one-piece or two-piece unit.
The one-piece reusable unit consists of a bag having a bottom valve or other closure means and a permanently bonded rubber or plastic faceplate. The faceplate has a centrally located opening for the stoma and can be attached directly to the body by means of latex cement or a double sided pressure sensitive adhesive disk. It is also common to adhesively attach the faceplate to a skin barrier which fits around the stoma rather than directly to the skin. For added security, a pressure plate having a belt attachment and a plastic or metal ring that fits between the faceplate and the bag can be employed. After several days the adhesive bond between the faceplate and the body or skin barrier will weaken and the unit will be removed. The unit is cleaned and residual adhesive is removed from the faceplate so that it can be reapplied. Eventually, the entire unit except for the pressure plate will have to be discarded due to erosion or odor build-up in the bag.
One-piece semi-permanent units for use with an ileostomy stoma having a karaya sealing ring bonded to the faceplate are commercially available.
The two-piece reusable unit consists of a rubber flange having an opening for the stoma which is adhesively attached directly to the body or to a skin barrier and a separate bag having a bottom valve or other closure means which fits tightly over the flange.
Chen in U.S. Pat. No. 3,339,546 describes a bandage having an adhesive layer consisting of a mixture of gelatin, pectin, sodium carboxymethylcellulose, and polyisobutylene and a water insoluble polyethylene film. This bandage is currently employed as a skin barrier by ostomates and is also available with a permanently attached flange.
Other commercially available skin barriers contain a cloth mesh layer or polyethylene web sandwiched between two adhesive layers. The adhesive layers comprise a conventional pressure sensitive adhesive and a hydrocolloid.
Further attempts have been made to develop ostomy sealing washers of materials other than the karaya-glycerol gel described by Marsan in U.S. Pat. No. 3,302,647. For example, Pratt in U.S. Pat. No. 3,612,053 describes an ostomy sealing washer formed from an oil-extended block copolymer having a water activatable adhesive on one surface, Marsan in U.S. Pat. Nos. 3,712,304 and 3,799,166 describes an ostomy seal made from starch and gelatinized starch cross-linked with glyoxal, Marsan in U.S. Pat. No. 3,878,847 describes a thin membrane that contacts the stoma, Marsan in U.S. Pat. No. 3,908,658 describes an ostomy seal formed from a gel of mineral oil, styreneisobutylene copolymer and an ethylene-vinyl acetate copolymer, and Kross in U.S. Pat. Nos. 3,877,431 and 3,980,084 describes ostomy seals formed from polymeric materials.